Weight Loss Of Benaglutide Versus Metformin For Overweight And Obese Patients: A Randomised,open,controlled And Single-site Clinical Trail

Aims:To compare the efficacy and safety of weight loss between benaglutide and metformin in overweight and obese patients.Methods:Seventy-eight non-diabetic patients aged 18-70 years with a body mass index(BMI)28-37.5 kg / m2 or BMI 24-28 kg / m2 accompanied by obesity-related complications were randomly(1:1)allocated to receive benaglutide or metformin treatment for 12 weeks.The final dose of benaglutide was 0.2 mg subcutaneous injections before three meal per day,and metformin was 0.5 g orally before three meal per day.All subjects were given calorie restrict diet and exercise instruction.The primary end points were the changes of body weight from baseline and the percentage of patients whose body weight decreased ≥5% and ≥10% from baseline.Secondary end points included the changes of BMI,waist circumference(WC),glucolipid metabolism,insulin resistance index(HOMA-IR),body composition(dual energy X-ray,body composition analyzer),improvement of fatty liver(Fibro Touch,transient elastography technology),and adverse events.Results:1.At 12 weeks,32 patients in each group completed the study.Body weight decreased 9.5 ± 0.8%(9.1 ± 0.9 kg)(P < 0.01)in the benaglutide group,and 5.1± 0.9%(4.5 ± 0.8 kg)(P < 0.01)in the metformin group.Patients in the benaglutide group lost more weight(4.4 ± 1.2%,4.5 ± 1.2kg)than those in the metformin group(P < 0.01).and(P < 0.01),Percentage of patients with weight loss ≥ 5% was 90.6% in benaglutide group and was 46.9% in the metformin group and with weight loss ≥ 10% were 40.6% and 12.5%,respectively(P <0.05).2.Body mass index,WC,percentage of body fat mass,body fat mass(including total,trunk,limb,android and gynoid),visceral fat area,and basal metabolic rates significantly decreased in the both groups(P < 0.01-0.05).The decreases in BMI,WC,percentage of body fat mass,and fat mass at above area were significantly greater in the benaglutide group than in the metformin group(P <0.01-0.05).Greater reduction of body fat than lean tissure was found with benaglutide treatment of same area(P < 0.01-0.05).In the metformin group,more fat mass than lean tissue mass decreased in the total and trunk,and android.3.Hepatic fibrosis index and controlled attention parameter,and serum alanine aminotransferase(ALT)and aspartate aminotransferase(AST)decreased in the both groups(P < 0.01 ~ 0.05),there was no difference between the two groups.4.After 12 weeks,blood lipid profile,glycated hemoglobin,and serum glucose levels at 0 min,30 min and 120 min during the glucose tolerance test were no changed in the both group.Beneglutide treatment resulted in a significant decrease in 0 min,30 min,120 min insulin and insulin resistance index(HOMA-IR)(P < 0.05),while no change was detected in the metformin group.Serum uric acid(UA)decreased only by benaglutide treatment(P < 0.01),and greater decrease in serum UA was observed in the benaglutide group than in the metformin group(P < 0.05).5.There was no difference in total adverse events between the two groups,while gastrointestinal and dizziness were more common under benaglutide treatment(P< 0.05).The same number of subjects withdrawn from the trial due to adverse reactions.Conclusions:For overweight and obese patients without diabetes,Treatment with benaglutide for 12 weeks achieved greater weight loss and reduction of fat mass than with metformin.Gastrointestinal and dizziness were more common with benaglutide treatment.Weight loss by benaglutide mainly resulted from the reduction of fat mass than lean tissue mass,which was beneficial for improving potential metabolic disorders.Benaglutide might be an option for Chinese overweight and obese patients when lifestyle intervention is useless.